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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantGUIDANT CORP.
4100 hamline avenue north
st. paul, MN 55112-5798
PMA NumberP030005
Date Received03/24/2003
Decision Date01/26/2004
Product Code NKE 
Docket Number 04M-0064
Notice Date 02/24/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE CONTAK RENEWAL TR. THE DEVICE IS INDICATED S FOLLOWS: THE CONTAK RENEWAL TR PULSE GENERATOR IS INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION). THE DEVICE PROVIDES ATRIAL-VENTRICULAR TRACKING MODES TO HELP PRESERVE AV SYNCHRONY, AND ADAPTIVE-RATE PACING FOR PATIENTS WHO WOULD BENEFIT FROM ADJUSTED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S150 S151 S024 S027 S028 S029 S144 S145 S146 S152 S153 S154 
S155 S061  S072 S101 S102 S094 S096 S108 S063 S064 S044 
S056 S004 S005 S006 S039 S040 S104 S130 S085 S086 S097 S098 
S099 S116 S117 S118 S105 S106 S082 S083 S109 S110 S123 S124 
S125 S126 S076 S077 S078 S080 S060 S058 S052 S053 S048 S018 
S019 S020 S021 S022 S023 S055 S037 S002 S003 S041 S042 S043 
S057 S059 S008 S009 S010 S011 S012 S013 S014 S015 S016 S046 
S047 S030 S031 S032 S033 S034 S035 S069 S070 S071 S062 S054 
S001 S128 S129 S119 S120 S121 S122 S114 S115 S111 S112 S113 
S107 S100 S093 S084 S081 S092 S103 S131 S087 S088 S089 S090 
S073 S074 S075 S079 S220 S221 S222 S223 S224 S225 S218 S219 
S226 S227 S208 S209 S202 S203 S132 S133 S134 S135 S136 S137 
S138 S139 S140 S141 S142 S143 S147 S148 S149 S156 S157 S158 
S159 S160 S161 S162 S163 S164 S165 S166 S167 S168 S169 S170 
S171 S172 S173 S174 S175 S176 S178 S179 S180 S181 S182 S183 
S184 S185 S186 S187 S188 S189 S190 S191 S192 S193 S194 S195 
S196 S197 S198 S199 S200 S201 S049 S050 S051 S204 S205 S206 
S207 S210 S211 S212 S213 S214 S215 S216 S217 S065 S067 S068 
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